Author Interviews, Heart Disease, JAMA, Lipids / 03.07.2024
Lerodalcibep in Patients With or at High Risk of Cardiovascular Disease
MedicalResearch.com Interview with:
[caption id="attachment_62223" align="alignleft" width="150"] Dr. Stein[/caption]
Evan A Stein MD PhD FACC
COO/CSO
LIB Therapeutics
Cincinnati. OH USA 45227
MedicalResearch.com: What is the background for this study?
Response: Cardiovascular disease (CVD) remains the main cause of morbidity and mortality worldwide and is increasing in rapidly industrializing countries and is projected to cause more than >20 million deaths annually over the next 15 years. Low-density lipoprotein cholesterol (LDL-C) is well established as a major, easily modifiable, risk factor for CVD. Reductions with statins and, more recently, PCSK9 inhibitors, all agents which directly or indirectly upregulate the LDL receptor and enhance LDL-C clearance, have demonstrated CVD event reductions in cardiovascular outcome trials. Extensive data from these trials, provide a rough estimate that every 40 mg/dL reduction in LDL-C will reduce the risk of major CV cardiovascular events by 22% to 24%. Furthermore, trials with PCSK9 inhibitors added to statins which achieve substantial additional LDL-C reduction show and CVD event reduction remains linear to very low LDL-C levels without signals of adverse events.
Based on this body of evidence, recent revisions to national and international guidelines, now advocate for greater LDL-C reductions and lower LDL-C treatment goals, for patients not achieving these goals on statins alone. The current consensus target goal for LDL-C in patients with CVD, or who are at very-high risk for of CVD, is now less than <55 mg/dL, and <70 mg/dL for those at high risk.
This global trial of over 900 patients with CVD, or at very or high risk for CVD, on maximally tolerated statins assessed the 52-week efficacy and safety of monthly lerodalcibep.
Dr. Stein[/caption]
Evan A Stein MD PhD FACC
COO/CSO
LIB Therapeutics
Cincinnati. OH USA 45227
MedicalResearch.com: What is the background for this study?
Response: Cardiovascular disease (CVD) remains the main cause of morbidity and mortality worldwide and is increasing in rapidly industrializing countries and is projected to cause more than >20 million deaths annually over the next 15 years. Low-density lipoprotein cholesterol (LDL-C) is well established as a major, easily modifiable, risk factor for CVD. Reductions with statins and, more recently, PCSK9 inhibitors, all agents which directly or indirectly upregulate the LDL receptor and enhance LDL-C clearance, have demonstrated CVD event reductions in cardiovascular outcome trials. Extensive data from these trials, provide a rough estimate that every 40 mg/dL reduction in LDL-C will reduce the risk of major CV cardiovascular events by 22% to 24%. Furthermore, trials with PCSK9 inhibitors added to statins which achieve substantial additional LDL-C reduction show and CVD event reduction remains linear to very low LDL-C levels without signals of adverse events.
Based on this body of evidence, recent revisions to national and international guidelines, now advocate for greater LDL-C reductions and lower LDL-C treatment goals, for patients not achieving these goals on statins alone. The current consensus target goal for LDL-C in patients with CVD, or who are at very-high risk for of CVD, is now less than <55 mg/dL, and <70 mg/dL for those at high risk.
This global trial of over 900 patients with CVD, or at very or high risk for CVD, on maximally tolerated statins assessed the 52-week efficacy and safety of monthly lerodalcibep.
Dr. Li Li[/caption]
Li Li, M.D., Ph.D., M.P.H
Walter M. Seward Professor
Chair of Family Medicine
Director of population health
University of Virginia School of Medicine
Editor-in-chief of The BMJ Family Medicine
Dr. Li joined the U.S. Preventive Services Task Force in January 2021
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Task Force reviewed the latest available evidence to evaluate whether screening all children and adolescents who are 20 years old or younger for high cholesterol improves their heart health into adulthood.
At this time, there is not enough evidence to determine whether or not screening all kids is beneficial, so we are calling for additional research on the effectiveness of screening and treatment of high cholesterol in kids and teens.
Matt Spick[/caption]
Matt Spick, Post-Graduate Researcher
University of Surrey
Faculty of Engineering and Physical Sciences
Guildford, UK
MedicalResearch.com: What is the background for this study? Are you measuring lipids or the virus?
Response: In this study, we aimed to detect what the virus does to us, rather than the virus itself. The gold standard for detecting COVID-19 is the RT-PCR test, but by their nature, PCR tests only provide diagnostic information, and at times during the pandemic the availability of PCR tests has been a bottleneck for the identification of the disease. Our goal was to investigate a novel method for the diagnosis of COVID-19, at the same time as learning more about what the disease does to us through lipidomics.
Salim S. Virani, MD, PhD, FACC, FAHA, FASPC
Professor, Section of Cardiovascular Research
Director, Cardiology Fellowship Training Program
Baylor College of Medicine
Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center
Co-Director, VA Advanced Fellowship in Health Services Research & Development at the Michael E. DeBakey VA Medical Center, Houston, TX
Investigator, Health Policy, Quality and Informatics Program
Michael E. DeBakey Veterans Affairs Medical Center HSR&D Center of Innovation
Houston, TX @virani_md
MedicalResearch.com: What is the background for this study? What are the main findings? What do you think accounts for the gender differences?
Response: We know that women with ischemic heart disease (IHD) have lower prescription rates for statin and high-intensity statin therapy. In this study, we assessed whether the same trends hold true for women with other forms of atherosclerotic cardiovascular disease (ASCVD) i.e. women with peripheral artery disease (PAD) or ischemic cerebrovascular disease (ICVD). Maximally tolerated statin therapy is a Class-I indication in patients with clinical ASCVD which includes PAD and ICVD.
We also assessed statin adherence among men and women with PAD and ICVD.
Lastly, we performed exploratory analyses to assess whether statin therapy, statin intensity, and statin adherence in women with PAD and ICVD were associated with cardiovascular outcomes and/or mortality. 
Dr. Jensen[/caption]
Majken K. Jensen, Ph.D.
Adjunct Professor of Nutrition
Harvard T.H. Chan School of Public Health &
Professor in the Department of Public Health
University of Copenhagen, Copenhagen, Denmark
MedicalResearch.com: What is the background for this study?
Response: Alzheimer’s disease and other dementias are highly prevalent conditions. According to the Alzheimer’s Association, 50 million people are currently living with Alzheimer’s disease or other dementias worldwide. Lower apolipoprotein E in plasma is a risk factor for dementia, but the underlying biological mechanisms are not fully understood. Thus, we investigated the role of apolipoprotein E overall and in lipoproteins with distinct metabolic functions in relation to cognitive function and dementia risk..
